Regulatory Developments

The U.S. Environmental Protection Agency (EPA) issued on October 16, 2018, a proposed rule that would establish significant new use rules (SNUR) under the Toxic Substances Control Act (TSCA) for 13 chemical substances that are the subject of premanufacture notices (PMN). 83 Fed. Reg. 52179. The proposed rule is significant. Unlike other recent SNURs (i.e., those acted on since entry into force of amended TSCA), the 13 chemical substances are not also subject to consent orders. For this reason, the preamble contains novel language to address the new circumstances and legal issues encountered in the proposed rule. The proposed SNURs would require persons who intend to manufacture (defined by statute to include import) or process any of the 13 chemical substances for an activity that is designated as a significant new use to notify EPA at least 90 days before commencing that activity. The required notification will initiate EPA’s evaluation of the intended use within the applicable review period. Persons may not commence the manufacture or processing for the significant new use until EPA has conducted a review of the notice, made an appropriate determination on the notice, and has taken such actions as are required with that determination. Comments on the proposed SNURs are due November 15, 2018.

The proposed rule states that under TSCA Section 5(a)(2), EPA’s determination that a use of a chemical substance is a significant new use must be made after consideration of all relevant factors, including:

The projected volume of manufacturing and processing of a chemical substance;

The extent to which a use changes the type or form of exposure of human beings or the environment to a chemical substance;

The extent to which a use increases the magnitude and duration of exposure of human beings or the environment to a chemical substance; and

The reasonably anticipated manner and methods of manufacturing, processing, distribution in commerce, and disposal of a chemical substance.

For each of the 13 chemical substances, the proposed rule provides the following information:

PMN number;

Chemical name (generic name, if the specific name is claimed as confidential business information (CBI));

Information identified by EPA that would help characterize the potential health and/or environmental effects of the chemical substances if a manufacturer or processor is considering submitting a significant new use notice (SNUN) for a significant new use designated by the SNUR.

EPA states that this information may include testing not required to be conducted but that would help characterize the potential health and/or environmental effects of the PMN substance. According to the proposed rule, any recommendation for information identified by EPA was made based on EPA’s consideration of available screening-level data, if any, and other available information on appropriate testing for the chemical substance. Further, the proposed rule states that any such testing identified by EPA that includes testing on vertebrates was made after consideration of available toxicity information, computational toxicology and bioinformatics, and high-throughput screening methods and their prediction models. EPA also recognizes that whether testing/further information is needed will depend on the specific exposure and use scenario in the SNUN. EPA “encourages all SNUN submitters to contact EPA to discuss any potential future testing.”

Commentary

All previous SNURs proposed or promulgated for PMNs being considered under new TSCA were cases where EPA had negotiated orders under Section 5(e) and thus were so-called “5(e) SNURs.” Based on our experience, there are many PMN chemicals for which some regulatory requirement may be needed to meet the provisions of amended TSCA, but we do not believe that a Section 5(e) order is needed in all such cases. The proposed SNUR is interesting, important, and controversial, as this is the first time under the new law for which EPA is proposing to apply SNUR authority to non-5(e) order PMN cases.

In the proposed rule, EPA has emphasized that all of the subject PMN chemicals were “undergoing PMN review” when the proposed rule was signed (October 5, 2018). The proposed rule explains that this means that none of the chemicals was presently in commerce, as a Notice of Commencement (NOC) of manufacture or import had not been received and the chemicals have not been added to the TSCA Inventory. Thus, EPA concludes the proposed significant new uses are not ongoing.

EPA also took the novel step in the proposed rule of designating a given date (October 10, 2018) in the preamble as the cutoff date for determining whether the new use is ongoing. EPA states that the objective of its approach is to ensure that a person cannot defeat a SNUR by initiating a significant new use before the effective date of the final rule. EPA also states that, following promulgation of the final SNUR, any such significant new use would have to cease upon the effective date of the final rule and be subject to advance notification requirements in the form of a SNUN. Under new TSCA, such notifications require EPA review, Section 5(a)(3) determinations, and regulatory action as needed.

Although not discussed in the preamble we have learned that since signature, EPA has made “not likely” Section 5(a)(3)(C) determinations for the 13 new chemicals included in the proposed rule. Thus, it appears that EPA believes it has sufficient information to make this determination under the conditions of use.

EPA is likely to receive many comments on this proposed SNUR from diverse stakeholders. We will hold off on offering any reactions until we have had the chance to think through the issues more carefully. We, nonetheless, commend EPA for taking this step and initiating consideration and debate on the approach it is proposing in the rule as a way to deal with these types of PMN chemicals and the issues presented by them. As we noted at the outset of this commentary, the rule is interesting, important, and controversial, and this will remain the case as we, other stakeholders, and EPA go forward in the rulemaking process which, after promulgation by EPA of the final rule, may invite one or more legal challenges to the approach taken.